Ocular Comfort and the "Aging" Lens (ERBIUM)

Refractive Error Clinical Trial

Official title:

Ocular Comfort and the "Aging" Lens (ERBIUM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198600
• Other study ID #: P-373-C-006
• Status: Completed
• Phase: N/A
• First received: September 9, 2010
• Last updated: July 26, 2012
• Start date: July 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial was to evaluate the factors affecting comfortable contact lens wear and how those factors affect contact lens replacement frequency.

Description:

Eligible participants began Phase 1, following either Cycle A or Cycle B, and crossing over to the second cycle after completing the first. After the Phase 1 results were evaluated, eligible participants entered Phase 2. After Phase 2 results were evaluated, participants who consistently reported the highest and the lowest comfort scores entered Phase 3 and were defined as either survivors or strugglers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• At least 17 years of age.

• Ocular exam in the last two years.

• Currently wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis with a monthly replacement schedule.

• Wearing contact lenses at least five days per week for a minimum of 10 hours each day.

• Able to wear lenses in the available power range with a best-corrected visual acuity of at least 20/32 in both eyes.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any ocular disease.

• Systemic condition that may affect a study outcome.

• Using any systemic or topical medications that may affect ocular health.

• Wears lenses on an extended or continuous wear schedule.

• Habitually wears multifocal lenses.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Habitual contact lens
Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription
• Lotrafilcon B contact lens
Commercially marketed silicone hydrogel contact lens
• Contact lens cleaning and disinfecting system (ClearCare)
Commercially marketed, hydrogen peroxide-based contact lens care system

Locations

Country	Name	City	State
Canada	University of Waterloo	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
CIBA VISION	University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 1	No
Primary	Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 1	No
Primary	Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 1	No
Primary	Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 15	No
Primary	Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 15	No
Primary	Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 15	No
Primary	Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 43	No
Primary	Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 43	No
Primary	Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 43	No